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FDA 510(k)

Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs

K-Number: K220353 · 2022-03-31

ApplicantNiujian Technology Co., Ltd.
Decision Date2022-03-31
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs is a medical device manufactured by Niujian Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-03-31 under approval number K220353. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs?

Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-03-31. It is manufactured by Niujian Technology Co., Ltd.. The 510(k) number is K220353.

When was Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs approved by the FDA?

Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2022-03-31, under approval number K220353.

What company makes Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs?

Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs is manufactured by Niujian Technology Co., Ltd..

What is the FDA product code for Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs?

The FDA product code for Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs is LZC.

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Related PubMed Literature

PMID: 41448934 [Regulatory Practices and Implications of FDA Approving New Drug Indication under the Medical Device Pathway]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025) PMID: 41343216 Describing Inconsistencies in Pediatric Labeling of Medical Devices. JAMA network open (2025) PMID: 40854178 Health Professional Students' Knowledge About FDA Drug and Medical Device Regulation. Academic medicine : journal of the Association of American Medical Colleges (2025)

Other Devices by Niujian Technology Co., Ltd.

K210706Nitrile Examination Gloves K220354Disposable Medical Synthetic Nitrile Examination Gloves

Related Devices (Code: LZC)

K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health K151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsMaxter Glove Manufacturing Sdn Bhd K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy DrugsGmp Medicare Sdn Bhd (F25) K172642Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTCareplus (M) Sdn Bhd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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